Coronary AtherosclerosisNCT00431717
Coronary Computed Tomography Angiography and SPECT in Asymptomatic Diabetes
An observational study of Coronary Atherosclerosis and Diabetes Mellitus, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography in asymptomatic patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Atherosclerosis, Diabetes Mellitus
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2006to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asymptomtaic type 2 diabetes mellitus with multiple risk factors
Who may be able to join
- Type 2 diabetes mellitus
- Age 50 ~ 75 years
- Duration of diabetes: more than 5 years
- More than two of the following risk factors in addition to diabetes:
- 1)dyslipidemia, 2)hypertension, 3)smoking, 4)family history of premature coronary artery disease
Who cannot join
- Angina pectoris or anginal equivalent symptoms
- Insulin pump user or history of ketoacidosis
- History of myocardial infarction, heart failure, or coronary revascularization
- Electrocardiographic evidence of Q-wave myocardial infarction, ischemic ST- segment or T-wave changes, or complete left bundle branch block
- Uncontrolled arrythmia
- Hypersensitivity to contrast dye
- Renal failure
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang hospital
Sungnam-si, Gyeonggi-do
About this study
Official title: Study Comparing Coronary Computed Tomography Angiography and SPECT to Detect Subclinical Coronary Atherosclerosis in Asymptomatic Diabetes
The purpose of this study is to compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography in asymptomatic patients with type 2 diabetes mellitus.
Read the detailed description
Coronary artery disease (CAD) is the leading cause of death in patients with diabetes. Patients with diabetes are known to have silent myocardial ischemia more frequently than those without diabetes. Furthermore, CAD in patients with diabetes frequently manifested in advance stage, and morbidity and mortality are higher than those without diabetes. Early screening and treatment of CAD in asymptomatic patients with diabetes might reduce high morbidity and mortality.
Myocardial perfusion single photon emission computerized tomography (SPECT) is known as a gold standard method in detecting silent myocardial ischemia in asymptomatic patients with diabetes. Despite of the power of detecting myocardial ischemia functionally, there are limitations of SPECT in diagnosing subclinical coronary atherosclerosis anatomically. In recent advance in technology, coronary CT angiography (CTA) could detect subclinical coronary atherosclerosis. However, there is a paucity of information comparing the diagnostic power between SPECT and CTA.
Therefore in our study, we compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography in asymptomatic patients with type 2 diabetes mellitus.
In this study, we will recruit asymptomatic patients with diabetes. At the time of enrollment, all patients will undergo two imaging studies (SPECT and CTA) within a few days apart. When patients had positive result in either study, they will undergo coronary angiography for confirmation. We will evaluate the results of two studies comparing with coronary angiography. When the patients are eligible for study, investigators will give information about the study and obtain written consent. The presence of chest pain symptom will be screened with Rose questionnaire. Medical history and physical examination will be performed, and baseline laboratory work-up will be performed. Investigators will evaluate the status of diabetic complication (retinopathy/nephropathy/cardiac autonomic neuropathy).
- Conditions
- Coronary Atherosclerosis, Diabetes Mellitus
- Keywords
- Coronary Atherosclerosis, Diabetes Mellitus
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startNov 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Huk-Jae Chang, MD, PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431717
- Sponsor's protocol ID
- B-0609/037-019
- Status last verified
- Aug 2008
- First submitted
- 5 Feb 2007
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing Coronary Computed Tomography Angiography and SPECT to Detect Subclinical Coronary Atherosclerosis in Asymptomatic Diabetes
- ClinicalTrials.gov ID
- NCT00431717
- Acronym / sponsor ID
- B-0609/037-019
- Conditions
- Coronary Atherosclerosis, Diabetes Mellitus
- Keywords
- Coronary Atherosclerosis, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 6 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography in asymptomatic patients with type 2 diabetes mellitus.
Detailed description
Coronary artery disease (CAD) is the leading cause of death in patients with diabetes. Patients with diabetes are known to have silent myocardial ischemia more frequently than those without diabetes. Furthermore, CAD in patients with diabetes frequently manifested in advance stage, and morbidity and mortality are higher than those without diabetes. Early screening and treatment of CAD in asymptomatic patients with diabetes might reduce high morbidity and mortality.
Myocardial perfusion single photon emission computerized tomography (SPECT) is known as a gold standard method in detecting silent myocardial ischemia in asymptomatic patients with diabetes. Despite of the power of detecting myocardial ischemia functionally, there are limitations of SPECT in diagnosing subclinical coronary atherosclerosis anatomically. In recent advance in technology, coronary CT angiography (CTA) could detect subclinical coronary atherosclerosis. However, there is a paucity of information comparing the diagnostic power between SPECT and CTA.
Therefore in our study, we compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography in asymptomatic patients with type 2 diabetes mellitus.
In this study, we will recruit asymptomatic patients with diabetes. At the time of enrollment, all patients will undergo two imaging studies (SPECT and CTA) within a few days apart. When patients had positive result in either study, they will undergo coronary angiography for confirmation. We will evaluate the results of two studies comparing with coronary angiography. When the patients are eligible for study, investigators will give information about the study and obtain written consent. The presence of chest pain symptom will be screened with Rose questionnaire. Medical history and physical examination will be performed, and baseline laboratory work-up will be performed. Investigators will evaluate the status of diabetic complication (retinopathy/nephropathy/cardiac autonomic neuropathy).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomtaic type 2 diabetes mellitus with multiple risk factors
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus
- Age 50 ~ 75 years
- Duration of diabetes: more than 5 years
- More than two of the following risk factors in addition to diabetes:
- 1)dyslipidemia, 2)hypertension, 3)smoking, 4)family history of premature coronary artery disease
Key exclusion criteria (7 listed)
- Angina pectoris or anginal equivalent symptoms
- Insulin pump user or history of ketoacidosis
- History of myocardial infarction, heart failure, or coronary revascularization
- Electrocardiographic evidence of Q-wave myocardial infarction, ischemic ST- segment or T-wave changes, or complete left bundle branch block
- Uncontrolled arrythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
Related trials for Coronary Atherosclerosis
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huk-Jae Chang, MD, PhD study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Atherosclerosis and Diabetes Mellitus, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2008.